LA JOLLA, Calif., Nov. 18 /PRNewswire/ -- Gail K. Naughton, Ph.D.,
President and Chief Operating Officer of Advanced Tissue Sciences, Inc., today
presented data from the pivotal and supplemental clinical trials of Dermagraft
in the treatment of diabetic foot ulcers at the Biomaterials of the Future
Conference in San Francisco. This marks the first time detailed data from the
supplemental clinical trial and pooled results from both trials have been
disclosed. The combined data shows that Dermagraft (within a specified
therapeutic range based on metabolic activity) is significantly more effective
than the control treatment, achieving complete healing of these severe ulcers
in 51% of the patients in twelve weeks.
Dermagraft is a living, fully-human dermal skin replacement. A Premarket
Approval (PMA) application for Dermagraft in the treatment of diabetic foot
ulcers is currently being reviewed by the U.S. Food and Drug Administration
(FDA) under its expedited review process. Subject to FDA approval, Advanced
Tissue Sciences will manufacture and Smith & Nephew plc will market Dermagraft
in the U.S. through a fifty-fifty joint venture.
The fifty-patient supplemental clinical trial was conducted to show the
equivalence of Dermagraft produced to commercial specifications. All patients
enrolled in the supplemental trial were treated with Dermagraft within the
specified therapeutic range.
The key conclusions presented today by Dr. Naughton were:
Comparable wound closure results were observed between total evaluable
patients treated with Dermagraft within a specified therapeutic range (i.e.,
produced to commercial specifications) in the supplemental and pivotal
clinical trials (51.3% versus 50.8%, respectively). When these results are
pooled, the Dermagraft patient group achieved a highly significant improvement
in complete healing of 51%, compared to 31.7% of the control group (p value =
0.002).
When data from total evaluable patients receiving Dermagraft in the
supplemental and pivotal clinical trials are pooled (both therapeutic and non-
therapeutic range patients), the Dermagraft patient group achieved a
statistically significant improvement in complete healing of 41.9%, compared
to 31.7% of the control group (p value = 0.042).
"The data presented today corroborates the results from our earlier study
in which Dermagraft healed more diabetic foot ulcers -- and healed them more
rapidly -- than standard therapy," said Dr. Naughton. She added: "The
potential benefits of Dermagraft to clinicians and the healthcare system could
be significant. Most importantly, Dermagraft could offer patients hope for
improving their quality of life."
Approximately 800,000 diabetic foot ulcer patients are treated in the
United States each year, 400,000 of which represent the Company's potential
initial U.S. target market of full-thickness ulcers. Dermagraft was recently
introduced in Canada, the United Kingdom and Finland, and product launches are
planned in several northern European countries before the end of 1997.
Further launches in other global markets are being planned throughout 1998,
subject to regulatory approvals.
Advanced Tissue Sciences, Inc. is a tissue engineering company utilizing
its proprietary core technology to develop and manufacture human tissue
products for tissue repair and transplantation. In addition to developing its
Dermagraft product, the Company is currently marketing Dermagraft-TC(TM), a
temporary covering for severe and partial-thickness burns, under approvals
from the FDA. The Company also is developing products for cartilage and
cardiovascular applications.
Smith & Nephew, a leading worldwide healthcare company with more than $1.5
billion in annual sales, has a highly successful track record in developing,
manufacturing and marketing a wide variety of innovative and technologically
advanced tissue repair products, primarily in the areas of bone, joints, skin
and other soft tissue. Smith & Nephew has extensive marketing and
distribution capabilities and sales in more than 90 countries.
The discussion contained in this press release relating to approval and
commercialization of the Company's products, market opportunities and
therapeutic benefits involves risks and uncertainties. No assurance can be
given that the Company will successfully obtain Food and Drug Administration
or other regulatory approvals of Dermagraft (or that any such approvals will
be obtained on a timely basis), scale up manufacturing processes, launch its
products within indicated timeframes, or successfully commercialize, or
significantly penetrate the markets for any such products. These and other
risks are detailed in the Company's publicly available filings with the
Securities and Exchange Commission including its Annual Report on Form 10-K
for the year ended December 31, 1996. Actual results may differ materially
from those currently anticipated as a result of such risks.
SOURCE Advanced Tissue Sciences, Inc.
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CONTACT: Beth A. Kriegel, Director, Investor Relations, Advanced Tissue Sciences, Inc., 619-450-5802, Mark A. Corbae, Director, Public Relations, Dermagraft Joint Venture, 619-657-5985
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